NCT06312722 · Urotronic Inc.
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
(PEAK)
What this study is about
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
View original scientific description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male subject ≥ 50 years old
- Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
- Willing to provide informed consent and comply with protocol required follow-up
Exclusion criteria
- Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
- Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \> 4 ng/mL with free PSA \< 25%.
- Active urinary tract infection (UTI) confirmed by culture
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- History of overt urinary incontinence requiring the use of pads
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Current post-void residual volume (PVR) \> 300 mL or catheter dependent bladder drainage
- Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec)
- Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
- Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- Obstructive median lobe in the opinion of the investigator
Where
- Little Rock, Arkansas
- Tampa, Florida
- Shreveport, Louisiana
- Las Vegas, Nevada
- Springfield, Oregon
- Austin, Texas
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations